Multimedia Informed Consent & PROMS in Laparoscopic Cholecystectomy
Research type
Research Study
Full title
To pilot the use of a Multimedia Application (the EIDO website: aboutmyop.org) to collect the largest PROMs (Patient Reported Outcome Measures) dataset in adult patients undergoing elective Laparoscopic Cholecystectomy for symptomatic gallstones in the UK, and to aid the informed consent process.
IRAS ID
166739
Contact name
Simon Parsons
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust Research and Innovation dept.
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
Patients referred with gallstone disease necessitating surgery (laparoscopic cholecystectomy) will be invited to engage with our on-line interactive website. This will allow a two-way exchange of information in a secure environment (N3 compliant) to inform the patient about the risks, benefits, alternatives to surgery (cholecystectomy), and post-operative expectations. Furthermore, it will inform clinicians about the patient's symptoms and history, and record a pre-operative Patient Reported Outcome Measure (PROM). The patient's understanding of the facts required for informed consent will be measured and a "Patient Health & Understanding Report" generated for hospital clinicians. This will form part of the electronic patient record, and will be a medico-legal document.
As with current practice patients will still attend their initial outpatient clinic appointment where they will meet a surgeon who will determine the appropriateness of surgery. Informed consent for surgery (cholecystectomy) will be obtained at this initial consultation facilitated by the information obtained from the "Patient Health & Understanding Report". The patient will then continue to interact with the on-line platform before and after their operation to ensure they are well informed and to monitor their post-operative progress.
7 days after surgery the patient will be prompted to interact with the website to answer questions about their progress and recovery. This will replace the existing telephone follow-up interaction. Any problems identified will trigger a protocol driven interaction between the hospital and the patient.
At 1, 3 and 6 months after surgery a post-operative PROMs questionnaire will be answered by the patient allowing comparison of pre- and post-operative PROMs. This study will lead to the largest PROMs assessment of the effectiveness of laparoscopic cholecystectomy, will study the feasibility of our multimedia platform application in assisting with the process of informed consent, and will determine whether telephone follow-up can be safely replaced by a protocol driven online system.
REC name
South West - Frenchay Research Ethics Committee
REC reference
16/SW/0088
Date of REC Opinion
29 Apr 2016
REC opinion
Further Information Favourable Opinion